GNH USA

Europe — EMA

Kaftrio

GNH USA supplies Kaftrio (Tezacaftor/Elexacaftor/Ivacaftor), a CFTR modulator for cystic fibrosis in patients aged 12 years and older with at least one

Tezacaftor, Elexacaftor, Ivacaftor

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What is Tezacaftor, Elexacaftor, Ivacaftor?

Tezacaftor/elexacaftor/ivacaftor, the active ingredient in Kaftrio, is a CFTR modulator presented as a elexacaftor 100 mg / tezacaftor 50 mg / ivacaftor 75 mg oral tablet for oral use. It is indicated for the treatment of cystic fibrosis in patients aged 12 years and older who carry at least one F508del mutation, improving the function of the defective CFTR protein.

GNH USA supplies Kaftrio as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, with distribution channels aligned to EU regulatory standards.

What is Tezacaftor, Elexacaftor, Ivacaftor used for?

Kaftrio is a CFTR modulator used in the management of cystic fibrosis, a genetic disorder affecting chloride transport. - Cystic fibrosis (patients ≥12 years with at least one F508del mutation): improves lung function and reduces pulmonary exacerbations. - Cystic fibrosis (patients ≥12 years with two F508del mutations): provides greater clinical benefit compared with single‑mutation therapy. - Cystic fibrosis (patients ≥12 years with one F508del and a minimal‑function mutation): expands treatment options for this genotype subgroup.

What are the side effects of Tezacaftor, Elexacaftor, Ivacaftor?

Kaftrio may cause a range of adverse reactions.

Common Side Effects: - Headache: mild to moderate intensity. - Diarrhea: may be watery and intermittent. - Nausea: often transient after dosing. - Abdominal pain: cramp‑like discomfort. - Rash: skin erythema or pruritus. - Elevated liver enzymes: mild transaminase increase.

Serious or Rare Side Effects: - Hepatitis: significant liver injury requiring monitoring. - Cataracts or retinal changes: visual disturbances reported. - Severe allergic reactions: anaphylaxis or angioedema. - Dyspnea: worsening respiratory symptoms. - Elevated bilirubin: possible jaundice.

What precautions apply to Tezacaftor, Elexacaftor, Ivacaftor?

Before initiating Kaftrio, several safety considerations should be observed. - Liver monitoring: obtain baseline liver function tests and repeat periodically. - Drug interactions: review concomitant CYP3A4 substrates and inhibitors. - Pregnancy and lactation: use only if potential benefit justifies potential risk. - Respiratory status: monitor for any worsening of pulmonary symptoms. - Adherence: take tablets with a fat‑containing meal to enhance absorption. - Store at ambient temperature: keep below 25 °C, in the original pack, and protect from moisture.

What does Tezacaftor, Elexacaftor, Ivacaftor interact with?

Kaftrio interacts with several medications that affect its metabolism and absorption.

Major Interactions (Avoid): - Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): may markedly reduce drug exposure. - Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may increase exposure and risk of toxicity. - High‑dose statins (e.g., simvastatin >20 mg): increased risk of myopathy.

Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inhibitors (e.g., erythromycin, clarithromycin): may modestly raise plasma levels. - Antacids containing aluminum or magnesium: may decrease absorption if taken concurrently. - Oral contraceptives: potential reduction in efficacy; consider alternative contraception.

Frequently asked questions

What is Kaftrio used for?+
Kaftrio is prescribed for the treatment of cystic fibrosis in patients aged 12 years and older who have at least one F508del mutation in the CFTR gene. By improving the quantity and function of the CFTR protein, it helps to enhance lung function, reduce pulmonary exacerbations, and support overall disease management.
How does Tezacaftor/Elexacaftor/Ivacaftor work?+
The combination contains two CFTR correctors (tezacaftor and elexacaftor) that assist the misfolded CFTR protein to reach the cell surface, and a CFTR potentiator (ivacaftor) that increases the channel’s opening probability. Together they restore chloride transport across epithelial cells, addressing the underlying defect in cystic fibrosis.
What is the usual dose of Kaftrio?+
The specific dosing regimen for Kaftrio is determined by the prescribing clinician based on the patient’s age, weight, genotype, and clinical status. Typically, the medication is taken as an oral tablet twice daily with a fat‑containing meal, but the exact schedule should follow the prescriber’s instructions.
Is Kaftrio safe during pregnancy or breastfeeding?+
Limited clinical data are available on the use of Kaftrio in pregnant or lactating individuals. It should only be used when the potential therapeutic benefit justifies any potential risk to the fetus or infant, and the decision should be made in consultation with a healthcare professional.
How do I order Kaftrio from GNH USA?+
To request Kaftrio, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA supplies hospitals, pharmacies, and procurement teams worldwide. After the enquiry, the sales team will verify trade or institutional credentials, then provide pricing, availability, shipping details, and any necessary import documentation.
How does Kaftrio compare with other CFTR modulators?+
Kaftrio contains the same three active components as other triple‑combination therapies such as Trikafta, offering comparable efficacy in patients with at least one F508del mutation. Differences may lie in formulation, regulatory approvals, and regional availability, but the core mechanism of correcting and potentiating CFTR function is shared.
What are the recommended storage conditions for Kaftrio?+
Kaftrio tablets should be stored at ambient temperature, below 25 °C, in their original packaging. Keep the product away from moisture, direct sunlight, and excessive heat to maintain stability throughout its shelf life.
How is Kaftrio administered?+
Kaftrio is taken orally as a tablet. The label advises swallowing the tablet whole with a meal that contains fat, which enhances absorption of the active ingredients. Doses are usually spaced about 12 hours apart, but patients should follow the exact schedule prescribed by their clinician.
What are the most serious risks to watch for while taking Kaftrio?+
Serious adverse events include significant liver injury (hepatitis), development of cataracts or other retinal changes, and severe allergic reactions such as anaphylaxis. Patients should be monitored regularly for liver function abnormalities and any visual disturbances, and they should seek immediate medical attention if signs of an allergic reaction appear.
Who should not use Kaftrio?+
Kaftrio is contraindicated in individuals with a known hypersensitivity to any of its components. Patients with severe hepatic impairment should avoid the medication, and those who are unable to take oral tablets with a fatty meal may not achieve adequate drug exposure. Clinicians should assess each patient’s medical history before initiating therapy.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Tezacaftor, Elexacaftor, Ivacaftor
Route
Oral Use
Manufacturer
Vertex Pharmaceuticals (Ireland) Limited
Origin
EU

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